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A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

NCT ID: NCT02040779

Last Updated: 2021-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-26

Study Completion Date

2014-12-24

Brief Summary

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This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Detailed Description

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Conditions

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Persistent Asthma

Keywords

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asthma breath-actuated inhaler beclomethasone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BDP 80 mcg BAI

40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

Group Type EXPERIMENTAL

Beclomethasone dipropionate breath-actuated inhaler

Intervention Type DRUG

Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

albuterol/salbutamol

Intervention Type DRUG

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

BDP 160 mcg BAI

80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

Group Type EXPERIMENTAL

Beclomethasone dipropionate breath-actuated inhaler

Intervention Type DRUG

Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

albuterol/salbutamol

Intervention Type DRUG

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Placebo BAI

Placebo breath-actuated inhaler (BAI) twice daily.

Group Type PLACEBO_COMPARATOR

Placebo breath-actuated inhaler

Intervention Type DRUG

Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

albuterol/salbutamol

Intervention Type DRUG

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Interventions

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Beclomethasone dipropionate breath-actuated inhaler

Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

Intervention Type DRUG

Placebo breath-actuated inhaler

Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

Intervention Type DRUG

albuterol/salbutamol

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Intervention Type DRUG

Other Intervention Names

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BDP bronchodilators

Eligibility Criteria

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Inclusion Criteria

* Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).
* Current asthma therapy: The patient is currently being treated with 1 of the following:

1\) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
* Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information

Exclusion Criteria

* The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
* The patient is a pregnant or lactating female or plans to become pregnant.
* The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
* The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.
* The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
* The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
* Other criteria apply, please contact the investigator for more information
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 10953

El Paso, Texas, United States

Site Status

Teva Investigational Site 12807

Houston, Texas, United States

Site Status

Teva Investigational Site 10950

New Braunfels, Texas, United States

Site Status

Teva Investigational Site 12813

Huntington Beach, California, United States

Site Status

Teva Investigational Site 10944

Mission Viejo, California, United States

Site Status

Teva Investigational Site 10946

Orange, California, United States

Site Status

Teva Investigational Site 10963

Rolling Hills Estates, California, United States

Site Status

Teva Investigational Site 10960

San Diego, California, United States

Site Status

Teva Investigational Site 10973

San Diego, California, United States

Site Status

Teva Investigational Site 10975

San Jose, California, United States

Site Status

Teva Investigational Site 10948

Centennial, Colorado, United States

Site Status

Teva Investigational Site 10958

Centennial, Colorado, United States

Site Status

Teva Investigational Site 10957

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 12814

Sarasota, Florida, United States

Site Status

Teva Investigational Site 10962

Tallahassee, Florida, United States

Site Status

Teva Investigational Site 12809

Savannah, Georgia, United States

Site Status

Teva Investigational Site 10947

Indianapolis, Indiana, United States

Site Status

Teva Investigational Site 10943

Iowa City, Iowa, United States

Site Status

Teva Investigational Site 10954

Baltimore, Maryland, United States

Site Status

Teva Investigational Site 12940

Bethesda, Maryland, United States

Site Status

Teva Investigational Site 10955

North Dartmouth, Massachusetts, United States

Site Status

Teva Investigational Site 10941

Minneapolis, Minnesota, United States

Site Status

Teva Investigational Site 10970

Columbia, Missouri, United States

Site Status

Teva Investigational Site 10968

Rolla, Missouri, United States

Site Status

Teva Investigational Site 10972

Bozeman, Montana, United States

Site Status

Teva Investigational Site 12941

Missoula, Montana, United States

Site Status

Teva Investigational Site 10942

Bellevue, Nebraska, United States

Site Status

Teva Investigational Site 10959

Skillman, New Jersey, United States

Site Status

Teva Investigational Site 10945

Raleigh, North Carolina, United States

Site Status

Teva Investigational Site 12810

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 10974

Sylvania, Ohio, United States

Site Status

Teva Investigational Site 12805

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 12942

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 10951

Tulsa, Oklahoma, United States

Site Status

Teva Investigational Site 10940

Lake Oswego, Oregon, United States

Site Status

Teva Investigational Site 10952

Medford, Oregon, United States

Site Status

Teva Investigational Site 10956

Portland, Oregon, United States

Site Status

Teva Investigational Site 12939

Pittsburgh, Pennsylvania, United States

Site Status

Teva Investigational Site 12806

Orangeburg, South Carolina, United States

Site Status

Teva Investigational Site 12811

Knoxville, Tennessee, United States

Site Status

Teva Investigational Site 10969

Austin, Texas, United States

Site Status

Teva Investigational Site 12812

Boerne, Texas, United States

Site Status

Teva Investigational Site 10949

Dallas, Texas, United States

Site Status

Teva Investigational Site 10961

San Antonio, Texas, United States

Site Status

Teva Investigational Site 12808

Waco, Texas, United States

Site Status

Teva Investigational Site 10967

Seattle, Washington, United States

Site Status

Teva Investigational Site 10964

Greenfield, Wisconsin, United States

Site Status

Countries

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United States

References

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Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017 Nov 8;38(6):419-430. doi: 10.2500/aap.2017.38.4089. Epub 2017 Sep 8.

Reference Type DERIVED
PMID: 28886758 (View on PubMed)

Other Identifiers

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BDB-AS-304

Identifier Type: -

Identifier Source: org_study_id